ACTion Fuser Pump, 400ml, 1-6 ml/hr, (no catheter) 418204400

GUDID 05707480132416

ACTion Fuser 400,1-6ml/hr,(no catheter set), bag and lock

Ambu A/S

Elastomeric infusion pump kit

• Primary Device ID: 05707480132416
• NIH Device Record Key: b8ebaaf8-2177-4670-99b4-cb2164bb68d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACTion Fuser Pump, 400ml, 1-6 ml/hr, (no catheter)
• Version Model Number: 418204400
• Catalog Number: 418204400
• Company DUNS: 305682023
• Company Name: Ambu A/S
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com

Device Dimensions

• Total Volume: 400 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between -15 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05707480132416 [Package]; Contains: 05707480132423; Package: [4 Units]; In Commercial Distribution
GS1	05707480132423 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061409

FDA Product Code

• MEB: PUMP, INFUSION, ELASTOMERIC

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-08-13
• Device Publish Date: 2018-07-13

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